Abstract
The identification of hyperandrogenism in polycystic ovary syndrome (PCOS) is concerning because of the poor accuracy of the androgen immunoassays (IA) and controversies regarding which androgens should be measured. The aim of our study was to evaluate the impact of the assessment of testosterone (T) and androstenedione (A) by liquid chromatography in tandem with mass spectrometry (LC/MS-MS), in the diagnosis of PCOS. We evaluated 131 patients referred for suspected PCOS. Fourteen patients in total were excluded, some because of other diagnosis (n = 7) or incomplete diagnostic workup (n = 7). We measured T and A both by IA and LC-MS/MS in the 117 subjects included. We calculated free T (fT) by the Vermeulen formula and recorded clinical and metabolic data. 73 healthy females served as controls to derive immunoassays (IA) and LC-MS/MS reference intervals for T, fT and A. PCOS was confirmed in 90 subjects by IA and in 93 (+3.3%) by LC-MS/MS. The prevalence of biochemical hyperandrogenism in PCOS by LC-MS/MS increased from 81.7% to 89.2% if A was also considered. The most frequently elevated androgens were fT (73.1%) and A (64.5%) and they had similar levels of accuracy in differentiating PCOS and controls (0.34 ng/dL, Sn 91% Sp 89%; 1.16 ng/mL, Sn 91% Sp 88%, respectively). Free testosterone correlated with body mass index (BMI), homeostatic model assessment (HOMA)-index, glycated hemoglobin (HbA1c), and sex-binding globulin (SHBG). The results confirm that LC-MS/MS is slightly more sensitive than IA in the diagnosis of PCOS with LC-MS/MS detecting higher levels of fT and A. Moreover, assessment of fT and A by LC-MS/MS had a similar level of accuracy in discriminating between PCOs and control subjects. Lastly, fT by LC-MS/MS correlates with adverse metabolic parameters.
Highlights
Polycystic ovary syndrome (PCOS) is a common endocrinological disorder, with a prevalence as high as 9–18% in females of reproductive age, and it is associated with reproductive and metabolic dysfunctions [1,2]
It is likely that the use of liquid chromatography in tandem with mass spectrometry (LC-MS/MS), the gold standard for steroids measurements, allowing simultaneous measurement of several androgens, may improve the diagnosis and phenotyping of PCOS patients [13]
body mass index (BMI) and waist were comparable between the two groups, insulin concentrations and homeostatic model assessment (HOMA)-index were significantly higher in PCOS patients, and HDL and Sex-hormone binding globulin (SHBG) concentrations were lower
Summary
Polycystic ovary syndrome (PCOS) is a common endocrinological disorder, with a prevalence as high as 9–18% in females of reproductive age, and it is associated with reproductive and metabolic dysfunctions [1,2]. Current guidelines recommend the use of reliable steroid measurement methods, this is not always feasible in clinical practice because of their inaccessibility and high costs. It is likely that the use of liquid chromatography in tandem with mass spectrometry (LC-MS/MS), the gold standard for steroids measurements, allowing simultaneous measurement of several androgens, may improve the diagnosis and phenotyping of PCOS patients [13]. This technique has had limited application in clinical practice because of its complexity, and its difficulty in preparing quality control samples, which increased with the number of analytes. A commercial product, developed for the measurement of steroid panels by LC-MS/MS, has become commercially available
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